Clinical trials in Denmark: Pharma companies excel at transparency, universities lag behind
Over half of clinical trials run by major universities and hospitals in Denmark are still missing results on the European trial registry, an analysis by TranspariMED shows.
In total, the 15 institutions and companies sponsoring the most drug trials in Denmark have failed to upload the results of 269 drug trials in violation of European transparency rules.
PERFORMANCE OF DANISH RESEARCH INSTITUTIONS
Three public institutions – Rigshospitalet (74 results missing), Aarhus University (50) and Odense University Hospital (37) between them account for over half of all missing results. In stark contrast, pharma companies collectively owe Danish patients the results of only 5 clinical trials.
The chart below further highlights the extent to which Danish companies outperform public institutions when it comes to clinical trial transparency. Companies occupy all the top places in the transparency league.
Novo Nordisk and ALK-Abello have a perfect compliance record.
Lundbeck and LEO Pharma also perform very strongly.
Genmab is the only commercial sponsor that disappoints, but even so, it easily outperforms all ten of the country’s largest non-commercial medical research institutions.
STRONG ENGAGEMENT BY THE DANISH REGULATOR
On the positive side, it appears that the Danish national medicines regulator Laegemiddelstyrelsen (DKMA) is ensuring that registry data is kept up to date.
Few if any completed Danish trials appear to be falsely marked as ‘ongoing’, making it easy for registry users to gain a comprehensive overview of national research efforts.
(In some European countries, including the Netherlands, Italy and France, registry data is such a mess that it is impossible to tell how many drug trials are ongoing or have been completed.)
Denmark is the first European country to introduce sanctions – including prison sentences – for sponsors that endanger patients and public health by violating European transparency rules.
The Danish regulator’s proactive approach seems to be having a positive impact. While TranspariMED does not have comprehensive historical data on trial reporting in Denmark, it appears that most institutions in the country are now rapidly uploading their missing results.
TranspariMED will continue to track Danish institutions’ progress in this blog over the coming months.
Danish institutions may wish to use TranspariMED’s collection of transparency tools to help inform their trial reporting efforts. Readers can use the EU Trials Tracker to check the performance of smaller Danish trial sponsors not discussed in this report. Barriers to the publication of academic drug trials in Denmark are discussed in this 2017 study.
HOW CAN DENMARK ENSURE THAT RESULTS OF ALL TRIALS ARE MADE PUBLIC?
The data and discussion above only cover the minority of drug trials run in Denmark that are subject to European disclosure rules (so-called CTIMPs). Other trials, including trials of medical devices and surgical techniques, are more loosely regulated and not captured by the Tracker.
In order to ensure that the results of all clinical trials are made public as demanded by the WHO, stakeholders in Denmark should consider developing a comprehensive national transparency strategy covering all interventional clinical trials.
*Note on methodology:
The analyses above are based on data from the EU Trials Tracker. TranspariMED combined data from two separate Tracker entries for two sponsors:
Data for “Herlev and Gentofte Hospital” aggregates data from separate Tracker entries for Herlev and Gentofte Hospital and for Gentofte Hospital.
Data for “Rigshospitalet” aggregates data from separate Tracker entries for Rigshospitalet Glostrup and for Rigshospitalet.
If sponsors believe that the EU Trials Tracker incorrectly allocates trials to their portfolios, they should directly contact the Tracker team and ask them to re-allocate those trials. Please note that the Tracker is run by the DataLab at Oxford University, not by TranspariMED.